Crista Casey is a Director, Project Management, at Clinipace.
In December, the National Institutes of Health (NIH) released a draft policy stating it is promoting the use of single Institutional Review Boards (IRBs) for multi-site studies instead of multiple IRBs. The draft covers NIH-funded, multi-site studies in the U.S., including those studies supported by grants, contracts or the NIH intramural program. According to NIH, wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio.
Francis S. Collins, M.D., PhD, Director of the NIH, explains: “By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
At Clinipace, we have, in fact, been seeing more sites with IRB options (local, local or central, or a central IRB as their local IRB) and agree there are many benefits to the approach of using a single IRB. Numerous sites having the ability to use a central IRB can decrease submission and approval processing time and allows sponsors and CROs to relieve sites of administrative tasks. This allows site teams to focus on being the front line of research. By decreasing the administrative workload on sites, we’re also seeing efficiencies in time to submission when single IRBs are used because site teams are not juggling patient related and administrative tasks.
Typically, site start-up routinely follows a bell curve over a 4- to 6-month timeframe in the United States. More sites using one IRB should yield a bolus of sites activated earlier in the trial, changing the routine bell curve distribution. This will better positioning studies for timely enrollment and healthy cost/quality/time outcomes.
However, while using a single IRB is extremely favorable and, in theory, result in a more concise audit, it’s important to note that it isn’t without risk. One potential area of concern is any IRB error (in the submission or approval process) affecting multiple sites.
Public comments on the draft policy are currently being accepted by the NIH, and it will likely lead to more discussion and commentary. Do you agree that a single IRB review for multiple studies would be beneficial? What other, if any, downfalls do you think there are? We would love to hear your feedback; please share your comments below.